MASTERING THE IMPLEMENTATION AND MANAGEMENT OF A QUALITY MANAGEMENT SYSTEM (QMS) BASED ON ISO 13485

1. CERTIFIED ISO 13485
LEAD IMPLEMENTER
MASTERING THE IMPLEMENTATION AND MANAGEMENT OF A QUALITY MANAGEMENT SYSTEM
(QMS) BASED ON ISO 13485
SUMMARY
This five-day intensive course enables the participants to develop the necessary expertise to
support an organization in implementing and managing a Quality Management System (QMS)
based on ISO 13485. Participants will also gain a thorough understanding of best practices
used to implement quality processes based on requirements from ISO 13485.
COURSE AGENDA
DAY 1: Introduction to Quality Management System (QMS) concepts as required by ISO 13485
and initiation of a QMS
DAY 2: Planning the implementation of a QMS based on ISO 13485
DAY 3: Implementing a QMS based on ISO 13485
DAY 4: Controlling, monitoring and measuring a QMS and the certification audit of a QMS in
accordance with ISO 13485
DAY 5: Certification Exam
PECB’s 3 Hour Certified ISO 13485 Lead Implementer Exam is available in different languages. The candidates
who do not pass the exam will be able to retake it for free within 12 months from the initial exam date.
After successfully completing the exam, participants can apply for the credentials of Certified
ISO 13485 Lead Implementer.
For more information, please visit: www.pecb.org
GENERAL INFORMATION
▶▶ Certification fees are included in the exam price
▶▶ articipant manual contains more than 450 pages of
P
information and practical examples
▶▶ A participation certificate of 31 CPD (Continuing Professional
Development) credits will be issued to the participants
PECB
Certified
ISO 13485
Lead Implementer
For additional information, please contact us at info@pecb.org.